EDF Health

EDF and others take FDA to court to demand action on carcinogenic flavors petition

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 17, 2018

Tom Neltner, J.D., Chemicals Policy Director, and Maricel Maffini, Independent Consultant

FDA’s priority must be resolving safety concerns with
existing chemicals over approval of new ones.

On May 2, EDF and other consumer health advocates filed a lawsuit to force the Food and Drug Administration (FDA) to make a final decision on our food additive petition, which asked the agency to reverse its approvals of seven carcinogenic synthetic flavors. Earthjustice is representing EDF in this petition for a writ of mandamus to the court of appeals. We did not take this action lightly. However, with the statutory deadline for a decision passing more than 20 months ago, we saw little chance that FDA would act without court oversight.

Our food additive petition narrowly focused on one specific issue where the law and science were clear, and laid out our review of both the scientific literature and the law concluding that the seven chemicals were no longer safe. FDA formally accepted the petition for filing – essentially confirming it was complete – which triggered a 180-day deadline under the statute to make a final decision. That deadline passed in August 2016 without a decision by FDA.

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A path to leadership: Food packaging product stewardship considerations released

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 13, 2018

Tom Neltner, J.D., is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

Last week, we spent two days at a Chemical Watch food packaging conference with manufacturers and suppliers trying to better understand the process for bringing innovative products to market. They learned what the Food and Drug Administration (FDA) and other countries will demand and what challenges they need to anticipate. While regulatory aspects are complicated, the attendees often talked about the difficulties of navigating requirements from companies and reacting to consumer expectations about packaging chemicals.

These concerns were timely. On March 9, the Food Safety Alliance for Packaging (FSAP), a part of the Institute of Packaging Professionals, released “Food Packaging Product Stewardship Considerations,” a set of best practices. This marks the first public recognition by a sector of the packaging industry of the expectations and demands from food manufacturers, retailers, and consumers.

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This speaks volumes: Industry rushes in to defend EPA’s new TSCA regulations

By Richard Denison / Published: September 12, 2017

Richard Denison, Ph.D., is a Lead Senior Scientist.

Environmental Defense Fund has made no secret of our view that many elements of the final framework rules issued by the Trump EPA in July to implement recent reforms to the Toxic Substances Control Act (TSCA) are contrary to law and fail to reflect the best available science.  The rules EPA had proposed in January were heavily rewritten by a Trump political appointee, Dr. Nancy Beck, who until her arrival at the agency at the end of April was a senior official at the chemical industry’s main trade association, the American Chemistry Council (ACC).

In our view, the final rules largely destroyed the careful balance that characterized the efforts to reform TSCA and the final product of that effort, the Lautenberg Act.  In many respects, the final rules governing how EPA will identify and prioritize chemicals and evaluate their risks now mirror the demands of the chemical industry, reflected in comments they had submitted earlier – some of which Beck herself had co-authored.

These are among the reasons EDF as well as other NGOs and health and labor groups have had no choice but to file legal challenges to these rules.

Lest you have any doubt that the final rules are heavily skewed in industry’s direction, a development in these legal cases just yesterday should dispel it.  Read More »

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Twice in 2 weeks: National Academy of Sciences again strongly affirms federal government’s science, agrees formaldehyde is a known human carcinogen

By Richard Denison / Published: August 8, 2014

Richard Denison, Ph.D., is a Lead Senior Scientist. 

Just last week I blogged that a panel of the National Academy of Sciences (NAS) had fully backed the National Toxicology Program’s (NTP) listing of styrene as “reasonably anticipated to be a human carcinogen.”

Today a separate NAS panel strongly endorsed NTP’s listing of formaldehyde as a “known human carcinogen” in its 12th Report on Carcinogens (RoC).  As with styrene, this second NAS panel both peer-reviewed the RoC listing and conducted its own independent review of the formaldehyde literature – and in both cases found strong evidence to support NTP’s listing.  See the NAS press release here, which links to the full report.  Read More »

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ECHA keeps the ball rolling on Authorisation under REACH

By Alissa Sasso / Published: June 6, 2014

Alissa Sasso is a Chemicals Policy Fellow.

In our last update on the European Union’s Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), we noted a major milestone under the “A” of REACH, as the first application for an authorisation was passed to and is awaiting decision by the European Commission. The authorisation process is continuing to move along: as of May 19th, ECHA has received 13 applications for 35 uses of six different substances on the Authorisation list. Interest in ECHA’s authorisation work is also increasing, eliciting a greater variety of stakeholder input than in the first round.  Read More »

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A gift for mothers (and daughters, and all of us): New tools for breast cancer monitoring and prevention

By Rachel Shaffer / Published: May 12, 2014

Rachel Shaffer is a research assistant.

Our mothers are no doubt on our minds right now, after Mother’s Day weekend. And I am no exception, especially since, as I blogged about last year, this month is the anniversary of my own mother’s breast cancer diagnosis.

This year though, in addition to celebrating my mother’s recovery, I can find hope in a new report from researchers at the Silent Spring Institute that provides guidance to improve our ability to screen for and study potential breast carcinogens — thereby enhancing efforts to prevent this widespread disease. Good news, certainly… and a timely gift for all of the women in our lives.

This new report describes biomonitoring methods for 102 breast carcinogens with high exposure potential and identifies existing cohort studies into which these methods could be integrated immediately. These chemicals are among the 216 previously identified by the authors as chemicals linked to mammary gland tumors in rodents. By testing for exposure markers of these priority breast carcinogens in the population, researchers should be able to better identify and study high-risk groups, and regulators will be better able both to limit dangerous exposures and to demonstrate the public health benefits of these exposure reductions.

The full report is available online, but I want to highlight a few key themes that are particularly relevant to current scientific and political debates.  Read More »

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